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ISO 13485 - Quality Management System for Medical Devices

Prove your proficiency in supplying safe medical devices and services that reliably meet customer expectations and adhere to regulatory guidelines.

What is an ISO 13485 Quality Management System?

An ISO 13485 Quality Management System is a comprehensive framework designed to ensure that medical devices consistently:

Meet the regulatory requirements and standards set forth by governing bodies
Fulfil the needs and expectations of patients and healthcare providers
Guarantee the safety, efficacy and reliability of medical devices throughout their lifecycle

At its core, the goal of any QMS is to emphasise the systematic approach to identifying and mitigating risks associated with medical devices, while also striving to enhance product performance and overall patient outcomes.

What are the benefits of being certified to ISO 13485 for medical device manufacturers?

Established quality management systems (QMS), such as ISO 13485, FDA regulations, and other international standards, serve as benchmarks for compliance and continuous improvement within the medical device industry.

Regulatory Compliance: ISO 13485 helps medical device manufacturers meet global regulatory requirements, including EU MDR and U.S. FDA QSR.
Focus on Risk Management: ISO 13485 emphasizes risk management throughout the product lifecycle to enhance safety and reliability.
Continuous Improvement: ISO 13485 fosters continuous improvement through data-driven decisions, process monitoring, and corrective actions.
Enhanced Credibility and Market Access: ISO 13485 certification boosts credibility and market access by demonstrating quality and compliance.
Streamlined Processes and Documentation: ISO 13485 standardizes processes and documentation, improving operations, traceability, and product quality.

Implement a compliant ISO 13485 QMS

Patient Guard offers comprehensive support and expertise to help manufacturers implement ISO 13485 successfully.

Gap Analysis and Readiness Assessment
Comprehensive gap analyses to identify compliance shortfalls in manufacturers’ quality management systems

Customized Implementation Plan
Tailored implementation plans with specific tasks, timelines, and responsibilities for achieving ISO 13485 certification

Documentation Development
ISO 13485 documentation development and refinement, ensuring quality manuals, procedures, and records are comprehensive and clear

Training and Education
Training programs on ISO 13485 principles, standards interpretation, implementation best practices, and internal auditing techniques

Process Optimization
Process optimization to align with ISO 13485, enhancing quality controls, risk management, and continuous improvement mechanisms

Internal Auditing and Compliance Monitoring
Conduct internal audits to evaluate the effectiveness of quality management systems and prepare manufacturers for external ISO 13485 audits

Support During External Audits
Support with documentation preparation, auditor inquiries and navigating the audit process

Post-Implementation Support
Ongoing post-certification support, including periodic reviews, documentation updates, and assistance with regulatory changes to maintain ISO 13485 compliance.

Why medical device manufacturers choose Patient Guard

Clear

Making sure our customers understand the type of information they need to generate to become compliant.

Concise

Removing the jargon and complexity to deliver projects that are value for money and nurture customer relationships.

Precise

Being exact, accurate and careful at all times, so we deliver professional documentation.

Helpful

Advice, guidance, and holding our customer's hands throughout the process from start to finish.

Patient Guard have been a great support service to Cormed, providing help and advice promptly whenever requested. They have become a virtual department within Cormed enabling us to keep up to date and comply with the regulatory requirements whilst ensuring our QMS works for us at the same time.

Tracey Slater, Cormed